# K080904: Feel-Fine Insulin Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Feel Tech
- Decided: Jun 4, 2008 after 64 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973899 (1997). 2 ancestors in all.
30 later devices descend from it; 8 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033575: One.Click Needle, B.Braun Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K112332: Fine Ject Insulin Pen Needle (2012), 21 descendants of its own
- K120690: Insulin Pen Needle (2012), 20 descendants of its own
- K133059: Insulin Pen Needle (2014), 18 descendants of its own
- K161950: Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle (2017), 9 descendants of its own
- K181069: Disposable Insulin Pen Needle (2018), 3 descendants of its own

## Recalls of this device
- Oct 27, 2009 · Not classified · Z-0573-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0576-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0570-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0571-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0574-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0569-2010: Needles are becoming dislodged from the barrels.
- Oct 27, 2009 · Not classified · Z-0572-2010: Needles are becoming dislodged from the barrels

## Indications for use
These disposable sterile insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes.

Source page: https://510kreport.com/device/K080904
Methodology: https://510kreport.com/methodology